NCT05195307

Brief Summary

Anxiety and stress increase in primiparous pregnant women and especially in the third trimester of pregnancy. This study was conducted to investigate the effect of music therapy applied to pregnant women who will give birth for the first time and are in the last trimester of their pregnancy on anxiety and stress. The study is a randomized controlled trial. Pregnant women in the application group were regularly listened to music for 20 minutes a day for 10 days. In the study, pregnant women in the application and control group were trained by the researcher on preparing for normal delivery. The pregnant women who participated in the study completed the Personal Information Form, the State and Trait Anxiety Inventory and the Pregnancy Stress Rating Scale at the beginning. 10, the last day of study. on the day, the scales are repeated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

December 15, 2021

Last Update Submit

January 4, 2022

Conditions

Keywords

midwiferypregnancymusicanxietystress

Outcome Measures

Primary Outcomes (2)

  • The effect of ten-day music therapy on anxiety levels of pregnant women

    Pre-intervention, a personal information form and a State and Trait Anxiety Inventory (STAI I-II) (Oner and Le Compte, 1998) were used to assess the anxiety levels of pregnant women. The minimum score they will receive from the State and Trait Anxiety Inventory is 0, the maximum score is 80.

    The music therapy application lasted for 10 days. Through study completion the final test of the a State and Trait Anxiety Inventory (STAI I-II) was performed with pregnant women.

  • The effect of ten-day music therapy on stress levels of pregnant women

    Pre-intervention, a Pregnancy Stress Rating Scale (Akin and Erbil, 2018) (PSRS) were used to assess the stress levels of pregnant women. The minimum score they will receive from the Pregnancy Stress Rating Scale is 0, the maximum is 144.

    The music therapy application lasted for 10 days. Through study completion final test of the a Pregnancy Stress Rating Scale (PSRS) was performed with pregnant women.

Study Arms (2)

Music Group

EXPERIMENTAL

Application Group Pregnant women in the application group were regularly listened to music for 20 minutes a day for 10 days. In addition, the pregnant women in the application group were trained by the researcher on preparing for normal delivery.

Other: Music Group

Control Group

NO INTERVENTION

In the study, pregnant women in the control group were trained by the researcher on preparing for normal delivery.

Interventions

Pregnant women included in the practice group were given 20 minutes of music every day for ten days. Anxiety and stress levels of pregnant women were measured before and after the intervention.

Music Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women aged 18 and over,
  • Primiparous pregnants,
  • In the third trimester (28 and above gestational week),
  • Speaking and writing in Turkish,
  • Having no vision-hearing problems,
  • Having and using internet-supported online Web 2.0 tools,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ebru Ertaş, Master

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Neşe Çelik, Phd

    Eskisehir Osmangazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized study with an application and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 18, 2022

Study Start

November 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations